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FDA 510(k)

NEUROSCIENCE MAP-10 EEG

K-Number: K850430 · 1985-07-17

ApplicantNeuroscience, Inc.
Decision Date1985-07-17
Product CodeGWS
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROSCIENCE MAP-10 EEG is the device name listed in this FDA 510(k) record. The listed applicant is Neuroscience, Inc.. It received FDA 510(k) clearance on 1985-07-17 under 510(k) number K850430. The device is classified under product code GWS. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROSCIENCE MAP-10 EEG?

NEUROSCIENCE MAP-10 EEG is a medical device that received FDA 510(k) clearance on 1985-07-17. The listed applicant is Neuroscience, Inc.. The 510(k) number is K850430.

When did NEUROSCIENCE MAP-10 EEG receive FDA 510(k) clearance?

NEUROSCIENCE MAP-10 EEG received FDA 510(k) clearance on 1985-07-17, under 510(k) number K850430.

Who is the listed applicant for NEUROSCIENCE MAP-10 EEG?

The FDA 510(k) record lists Neuroscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROSCIENCE MAP-10 EEG?

The FDA product code for NEUROSCIENCE MAP-10 EEG is GWS.

Related Clinical Trials

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Other records listing Neuroscience, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K871931ISTAT SOFTWAREK870263NEUROMAPPER 1620K855232SOMATOSENSORY EVOKED POTENTIAL STIMULATOR

Related Devices (Code: GWS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K974718PERSYST PRISMPersyst Development Corp.K925735EEG ANALYZERBio-Scan, Inc.K912938RHYTHMStellate SystemsK894629NICOLET BEAM II SYSTEMNicolet Instrument Corp.K871931ISTAT SOFTWARENeuroscience, Inc.K871480STD-228 SPECTRAL TREND DISPLAYGrass-Telefactor Product Group

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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